JP4493334B2 - Hsa非含有組成物中のnesp/epoの安定化剤としてのl−メチオニン - Google Patents

Hsa非含有組成物中のnesp/epoの安定化剤としてのl−メチオニン Download PDF

Info

Publication number
JP4493334B2
JP4493334B2 JP2003524606A JP2003524606A JP4493334B2 JP 4493334 B2 JP4493334 B2 JP 4493334B2 JP 2003524606 A JP2003524606 A JP 2003524606A JP 2003524606 A JP2003524606 A JP 2003524606A JP 4493334 B2 JP4493334 B2 JP 4493334B2
Authority
JP
Japan
Prior art keywords
nesp
methionine
composition
epo
free
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
JP2003524606A
Other languages
English (en)
Japanese (ja)
Other versions
JP2005527470A (ja
JP2005527470A5 (https=
Inventor
リ,ティアンシェン
チャン,バイヨン,エス.
スロイ,クリストファー
Original Assignee
キリン−アムジエン・インコーポレーテツド
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=25483206&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=JP4493334(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by キリン−アムジエン・インコーポレーテツド filed Critical キリン−アムジエン・インコーポレーテツド
Publication of JP2005527470A publication Critical patent/JP2005527470A/ja
Publication of JP2005527470A5 publication Critical patent/JP2005527470A5/ja
Application granted granted Critical
Publication of JP4493334B2 publication Critical patent/JP4493334B2/ja
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18Growth factors; Growth regulators
    • A61K38/1816Erythropoietin [EPO]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06Antianaemics

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Diabetes (AREA)
  • Organic Chemistry (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
JP2003524606A 2001-08-30 2002-08-29 Hsa非含有組成物中のnesp/epoの安定化剤としてのl−メチオニン Expired - Lifetime JP4493334B2 (ja)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US09/945,517 US20030104996A1 (en) 2001-08-30 2001-08-30 L-methionine as a stabilizer for NESP/EPO in HSA-free formulations
PCT/US2002/027855 WO2003020299A1 (en) 2001-08-30 2002-08-29 L-methionine as a stabilizer for nesp/epo in hsa-free formulations

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2010052203A Division JP2010138195A (ja) 2001-08-30 2010-03-09 Hsa非含有組成物中のnesp/epoの安定化剤としてのl−メチオニン

Publications (3)

Publication Number Publication Date
JP2005527470A JP2005527470A (ja) 2005-09-15
JP2005527470A5 JP2005527470A5 (https=) 2006-10-05
JP4493334B2 true JP4493334B2 (ja) 2010-06-30

Family

ID=25483206

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2003524606A Expired - Lifetime JP4493334B2 (ja) 2001-08-30 2002-08-29 Hsa非含有組成物中のnesp/epoの安定化剤としてのl−メチオニン
JP2010052203A Pending JP2010138195A (ja) 2001-08-30 2010-03-09 Hsa非含有組成物中のnesp/epoの安定化剤としてのl−メチオニン

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2010052203A Pending JP2010138195A (ja) 2001-08-30 2010-03-09 Hsa非含有組成物中のnesp/epoの安定化剤としてのl−メチオニン

Country Status (10)

Country Link
US (1) US20030104996A1 (https=)
EP (1) EP1439848B1 (https=)
JP (2) JP4493334B2 (https=)
KR (1) KR100596610B1 (https=)
CN (1) CN100384468C (https=)
CA (1) CA2458386C (https=)
MX (1) MXPA04001774A (https=)
PL (1) PL374122A1 (https=)
TW (1) TWI327068B (https=)
WO (1) WO2003020299A1 (https=)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010138195A (ja) * 2001-08-30 2010-06-24 Kirin Amgen Inc Hsa非含有組成物中のnesp/epoの安定化剤としてのl−メチオニン

Families Citing this family (44)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PL219131B1 (pl) * 2000-05-15 2015-03-31 Hoffmann La Roche Ciekła kompozycja farmaceutyczna, sposób jej wytwarzania oraz jej zastosowanie
US7141544B2 (en) * 2003-10-10 2006-11-28 Baxter International, Inc. Stabilization of pharmaceutical protein formulations with small peptides
AU2006295340B2 (en) * 2005-08-05 2010-11-11 Amgen Inc. Stable aqueous protein or antibody pharmaceutical formulations and their preparation
US8137677B2 (en) * 2005-10-06 2012-03-20 Allergan, Inc. Non-protein stabilized clostridial toxin pharmaceutical compositions
US8168206B1 (en) 2005-10-06 2012-05-01 Allergan, Inc. Animal protein-free pharmaceutical compositions
TW200806317A (en) * 2006-03-20 2008-02-01 Wyeth Corp Methods for reducing protein aggregation
EP2170268A2 (en) * 2007-06-25 2010-04-07 Amgen, Inc. Compositions of specific binding agents to hepatocyte growth factor
WO2009009406A1 (en) * 2007-07-06 2009-01-15 Smithkline Beecham Corporation Antibody formulations
EP2219602A1 (en) 2007-11-15 2010-08-25 Amgen, Inc Aqueous formulation of erythropoiesis stimulating protein stablised by antioxidants for parenteral administration
EP2249801A2 (en) * 2008-02-07 2010-11-17 Amgen Inc. Stabilized protein compositions
CN117530912A (zh) 2008-08-15 2024-02-09 硬木药品公司 适合口服给药的鸟苷酸环化酶-c受体激动剂多肽的稳定的固体制剂
BRPI0918978A2 (pt) * 2008-09-10 2015-12-01 Genentech Inc composições e métodos a prevenção da degradação oxidativa das proteínas
CA2765220A1 (en) * 2009-07-14 2011-01-20 Biogen Idec Ma Inc. Methods for inhibiting yellow color and peroxide formation in a composition
CA2770077A1 (en) * 2009-08-06 2011-02-10 Ironwood Pharmaceuticals, Inc. Formulations comprising linaclotide
FR2954325B1 (fr) 2009-12-23 2012-02-03 Flamel Tech Sa Polymere amphiphile fonctionnalise par la methionine
US20110150837A1 (en) * 2009-12-23 2011-06-23 Flamel Technologies Amphiphilic polymer functionalized by methionine
MX2012007676A (es) * 2009-12-29 2012-08-03 Hoffmann La Roche Nueva formulacion de anticuerpo.
CN107412737A (zh) 2010-01-19 2017-12-01 韩美科学株式会社 长效g‑csf缀合物的液体制剂
EP2364690A1 (en) 2010-02-12 2011-09-14 Centro De Ingenieria Genetica Y Biotecnologia Orally administrable pharmaceutical pellet of epidermal growth factor
US8933030B2 (en) 2010-02-17 2015-01-13 Ironwwod Pharmaceuticals, Inc. Treatments for gastrointestinal disorders
DK2603232T3 (da) 2010-08-11 2019-12-09 Ironwood Pharmaceuticals Inc Stabile formuleringer af linaclotid
KR101303388B1 (ko) * 2010-10-26 2013-09-03 한미사이언스 주식회사 지속형 인터페론 알파 결합체의 액상 제제
US9708371B2 (en) 2011-08-17 2017-07-18 Ironwood Pharmaceuticals, Inc. Treatments for gastrointestinal disorders
AU2012328524B2 (en) 2011-10-28 2017-05-18 Excelse Bio, Inc. Protein formulations containing amino acids
AR092862A1 (es) * 2012-07-25 2015-05-06 Hanmi Pharm Ind Co Ltd Formulacion liquida de insulina de accion prolongada y un peptido insulinotropico y metodo de preparacion
US9663563B2 (en) 2013-03-12 2017-05-30 Sumitomo Dainippon Pharma Co., Ltd. Aqueous liquid composition
SG10201707477SA (en) * 2013-03-13 2017-10-30 Eleven Biotherapeutics Inc Chimeric cytokine formulations for ocular delivery
JP6541581B2 (ja) 2013-03-15 2019-07-10 グラクソスミスクライン、インテレクチュアル、プロパティー、(ナンバー2)、リミテッドGlaxosmithkline Intellectual Property (No.2) Limited 低濃度抗体製剤
EP3094735A1 (en) * 2014-01-13 2016-11-23 Amgen Inc. Regulating ornithine metabolism to manipulate the high mannose glycoform content of recombinant proteins
AR103173A1 (es) 2014-12-22 2017-04-19 Novarits Ag Productos farmacéuticos y composiciones líquidas estables de anticuerpos il-17
RU2599031C1 (ru) * 2015-08-11 2016-10-10 Общество с ограниченной ответственностью "АйВиФарма" Водная композиция рекомбинантного фолликулостимулирующего гормона человека (варианты)
EP3397243A1 (en) * 2015-12-30 2018-11-07 H. Hoffnabb-La Roche Ag Use of tryptophan derivatives for protein formulations
BR112019004935A2 (pt) 2016-09-13 2019-06-04 Allergan, Inc. composições de toxina clostridial não proteíca estabilizada
US11338018B2 (en) 2016-12-19 2022-05-24 Harrow Ip, Llc Adrenocorticotropic hormone-based pharmaceutical formulations and methods for fabricating and using thereof
WO2018142514A1 (ja) * 2017-02-01 2018-08-09 協和発酵キリン株式会社 ダルベポエチンを含む液体医薬組成物
US11110063B2 (en) 2017-08-25 2021-09-07 MAIA Pharmaceuticals, Inc. Storage stable sincalide formulations
KR102655498B1 (ko) 2017-09-07 2024-04-11 제이씨알 파마 가부시키가이샤 수성 의약 조성물
US20210283238A1 (en) 2018-08-07 2021-09-16 Glaxosmithkline Biologicals Sa Novel processes and vaccines
BR112021004649A2 (pt) * 2018-09-13 2021-06-01 F. Hoffmann-La Roche Ag formulação farmacêutica e uso de uma formulação
US20210251970A1 (en) 2018-10-10 2021-08-19 Presbyopia Therapies Inc Compositions and methods for storage stable ophthalmic drugs
US12180206B2 (en) 2021-11-17 2024-12-31 Lenz Therapeutics Operations, Inc. Aceclidine derivatives, compositions thereof and methods of use thereof
US20250032579A1 (en) * 2021-12-03 2025-01-30 Jecho Biopharmaceuticals Co., Ltd. Formulation, and preparation method therefor and use thereof
US11648247B1 (en) 2021-12-16 2023-05-16 Lenz Therapeutics, Inc. Compositions and methods for the treatment of presbyopia
US12414942B1 (en) 2024-03-15 2025-09-16 Lenz Therapeutics Operations, Inc. Compositions, methods, and systems for treating presbyopia

Family Cites Families (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6936694B1 (en) * 1982-05-06 2005-08-30 Intermune, Inc. Manufacture and expression of large structural genes
NZ210501A (en) * 1983-12-13 1991-08-27 Kirin Amgen Inc Erythropoietin produced by procaryotic or eucaryotic expression of an exogenous dna sequence
KR850004274A (ko) * 1983-12-13 1985-07-11 원본미기재 에리트로포이에틴의 제조방법
US4703008A (en) * 1983-12-13 1987-10-27 Kiren-Amgen, Inc. DNA sequences encoding erythropoietin
US4667016A (en) * 1985-06-20 1987-05-19 Kirin-Amgen, Inc. Erythropoietin purification
US4810643A (en) * 1985-08-23 1989-03-07 Kirin- Amgen Inc. Production of pluripotent granulocyte colony-stimulating factor
JPS63500636A (ja) * 1985-08-23 1988-03-10 麒麟麦酒株式会社 多分化能性顆粒球コロニー刺激因子をコードするdna
JPS6297229A (ja) * 1985-10-21 1987-05-06 Nec Kansai Ltd 螢光膜の形成方法
US4835260A (en) * 1987-03-20 1989-05-30 Genetics Institute, Inc. Erythropoietin composition
US5075222A (en) * 1988-05-27 1991-12-24 Synergen, Inc. Interleukin-1 inhibitors
US5372808A (en) * 1990-10-17 1994-12-13 Amgen Inc. Methods and compositions for the treatment of diseases with consensus interferon while reducing side effect
US5272135A (en) * 1991-03-01 1993-12-21 Chiron Ophthalmics, Inc. Method for the stabilization of methionine-containing polypeptides
US5581476A (en) * 1993-01-28 1996-12-03 Amgen Inc. Computer-based methods and articles of manufacture for preparing G-CSF analogs
TW497972B (en) * 1995-06-08 2002-08-11 Kirin Brewery Stable thrombopoietin (TPO)-containing lyophilized compositions
IL122732A0 (en) * 1997-01-15 1998-08-16 Akzo Nobel Nv Liquid gonadotropin-containing formulation its preparation and a device containing same
JP2000247903A (ja) * 1999-03-01 2000-09-12 Chugai Pharmaceut Co Ltd 長期安定化製剤
WO2001030320A1 (en) * 1999-10-22 2001-05-03 Amgen Inc. Biodegradable microparticles with novel erythropoietin stimulating protein
PL219131B1 (pl) * 2000-05-15 2015-03-31 Hoffmann La Roche Ciekła kompozycja farmaceutyczna, sposób jej wytwarzania oraz jej zastosowanie
WO2002011753A1 (en) * 2000-08-04 2002-02-14 Chugai Seiyaku Kabushiki Kaisha Protein injection preparations
US20030104996A1 (en) * 2001-08-30 2003-06-05 Tiansheng Li L-methionine as a stabilizer for NESP/EPO in HSA-free formulations

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010138195A (ja) * 2001-08-30 2010-06-24 Kirin Amgen Inc Hsa非含有組成物中のnesp/epoの安定化剤としてのl−メチオニン

Also Published As

Publication number Publication date
JP2005527470A (ja) 2005-09-15
EP1439848A4 (en) 2009-06-24
HK1075198A1 (zh) 2005-12-09
MXPA04001774A (es) 2004-11-22
CN100384468C (zh) 2008-04-30
EP1439848A1 (en) 2004-07-28
CA2458386A1 (en) 2003-03-13
KR100596610B1 (ko) 2006-07-06
EP1439848B1 (en) 2014-11-26
CN1592629A (zh) 2005-03-09
KR20040044194A (ko) 2004-05-27
US20030104996A1 (en) 2003-06-05
TWI327068B (en) 2010-07-11
WO2003020299A1 (en) 2003-03-13
PL374122A1 (en) 2005-10-03
JP2010138195A (ja) 2010-06-24
CA2458386C (en) 2012-05-08

Similar Documents

Publication Publication Date Title
JP4493334B2 (ja) Hsa非含有組成物中のnesp/epoの安定化剤としてのl−メチオニン
US5661125A (en) Stable and preserved erythropoietin compositions
EP0373679B1 (en) Stabilized hydrophobic protein formulations
ES2326498T3 (es) Formulacion liquida de g-csf.
EP0838221B1 (en) Lyophilized hgf preparations
WO2001064241A1 (en) Preparations stabilized over long time
US7459429B2 (en) Method of treating disturbances of iron distribution in inflammatory intestinal diseases
JPWO2001064241A1 (ja) 長期安定化製剤
CN100425283C (zh) 包含红细胞生成素的稳定的药物组合物
AU2003251284B2 (en) Stable pharmaceutical composition comprising erythropoietin
AU2010201600B2 (en) L-methionine as a stabilizer for NESP/EPO in HSA-free formulations
JPH10510841A (ja) トロンボポイエチン組成物
EP3125922B1 (en) Liquid pharmaceutical composition of conjugated erythropoietin
AU2002329947A1 (en) L-methionine as a stabilizer for NESP/EPO in HSA-free formulations
HK1075198B (en) L-methionine as a stabilizer for nesp/epo in hsa-free formulations
CA2545880C (en) Erythropoietin solution formulation
KR20060108040A (ko) 인 과립구 콜로니 자극인자 용액 제형
WO2007034509A2 (en) Recombinant granulocyte-colony stimulating factor formulation and process
KR20180049887A (ko) 페길레이션된 에리스로포이에틴을 포함하는 신규한 제제
HK1006812B (en) Stabilized hydrophobic protein formulations
JP2006241043A (ja) 炎症性肺疾患の予防及び治療薬

Legal Events

Date Code Title Description
A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20050818

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20060817

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20090428

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20090728

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20100223

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20100301

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20100406

A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20100406

R150 Certificate of patent or registration of utility model

Free format text: JAPANESE INTERMEDIATE CODE: R150

Ref document number: 4493334

Country of ref document: JP

FPAY Renewal fee payment (event date is renewal date of database)

Free format text: PAYMENT UNTIL: 20130416

Year of fee payment: 3

FPAY Renewal fee payment (event date is renewal date of database)

Free format text: PAYMENT UNTIL: 20130416

Year of fee payment: 3

FPAY Renewal fee payment (event date is renewal date of database)

Free format text: PAYMENT UNTIL: 20140416

Year of fee payment: 4

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

S201 Request for registration of exclusive licence

Free format text: JAPANESE INTERMEDIATE CODE: R314201

R350 Written notification of registration of transfer

Free format text: JAPANESE INTERMEDIATE CODE: R350

R153 Grant of patent term extension

Free format text: JAPANESE INTERMEDIATE CODE: R153

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

S531 Written request for registration of change of domicile

Free format text: JAPANESE INTERMEDIATE CODE: R313531

S533 Written request for registration of change of name

Free format text: JAPANESE INTERMEDIATE CODE: R313533

R350 Written notification of registration of transfer

Free format text: JAPANESE INTERMEDIATE CODE: R350

S531 Written request for registration of change of domicile

Free format text: JAPANESE INTERMEDIATE CODE: R314531

S533 Written request for registration of change of name

Free format text: JAPANESE INTERMEDIATE CODE: R314533

R350 Written notification of registration of transfer

Free format text: JAPANESE INTERMEDIATE CODE: R350

S221 Written request for registration of change of exclusive licence

Free format text: JAPANESE INTERMEDIATE CODE: R314221

R350 Written notification of registration of transfer

Free format text: JAPANESE INTERMEDIATE CODE: R350

EXPY Cancellation because of completion of term